A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Lymphoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

In brief

The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors or lymphoma. The study will be conducted in 2 parts.

Key facts

Study ID

NCT05093322

Run by

Hutchmed

People needed

13

Starts

2021-11-30

Expected to finish

2023-04-25

Last updated by the study team

2024-06-07

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: At time of study enrollment, patients must be
• For US Sites:
• Part 1 (including PK expansion cohort): ≥2 and <18 years of age;
• Part 2: ≥2 and ≤18 years of age;
• For EU/UK Sites:
• Part 1 (including PK expansion cohort): from birth to <18 years of age;
• Part 2: from birth to <18 years of age (except as noted below);
• Note: Patients <2 years of age will only be enrolled in Europe, however, enrollment of patients <2 years of age will not begin until definitive juvenile animal toxicity data is available.
• Diagnosis:
• Part 1 - Patients with any recurrent or refractory solid tumors or lymphoma (not central nervous system [CNS]) that have a known or expected dysfunction of VEGFR 1, -2, and -3; FGFR-1, or CSF-1R pathways (based on literature) are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse.
• Part 2 - Recurrent or refractory osteosarcoma (US and EU), Ewing sarcoma (US and EU), RMS (US and EU), or NRSTS (EU only). Patients must have had histologic verification of malignancy at original diagnosis or relapse.
• Disease status: Patients must have measureable or evaluable disease for part 1 dose escalation; for part 2, patients must have measurable disease by RECIST version 1.1.
• Therapeutic options: Patient's current disease state must be one for which there is no known curative therapy.
• Performance level: Karnofsky ≥50 for patients ≥16 and <18 years of age and Lansky ≥50 for patients <16 years of age, Eastern Cooperative Oncology Group (ECOG) ≤2 for patients ≥18 years of age.
• Adequate organ and bone marrow function as defined in the current protocol.
• Adequate cardiac function as indicated as defined in the current protocol.
• Patients with known bone marrow metastatic disease will be eligible for the study provided they meet the blood counts in the inclusion criteria as defined in the current protocol.
• Adequate BP control which is defined as a BP <95th percentile (≤ grade 1) for age, height, and sex.
• Informed consent: Provision of signed and dated written informed consent (parent/legal guardian if patient <18 years of age) and assent (from patients aged >7 years) prior to any study-specific procedures, sampling, and analyses.
• Patient must meet all defined Inclusion criteria as defined in the current protocol.

You may not qualify if…

• Patient must not meet any exclusion criteria as defined in the current protocol.
• Pregnant, breast feeding or planning on becoming pregnant.
• Patients is taking and prohibitive concomitant medications as outlined in the current protocol.
• Patients have an uncontrolled infection.
• Patients has had major surgery or significant traumatic injury within 28 days of the first dose.
• Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy and without clinical imaging evidence of SD for 14 days or longer.
• History of allergies to Surufatinib and/or Gemcitabine.

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Childrens Hospital Orange County — Orange, California, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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